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AES Pharma Wall & Walk-On Ceiling Cleanroom System

Walls

A r c h i t e c t u r a l D e t a i l s

Section one

Including PVC cove, UL Listed Raceway, & Integration to Flooring

AES PHARMA SYSTEM

Copyright 2007, AES Clean Technology, Inc. All Rights Reserved. The information in this document is subject to change without notice. AES assumes no responsibility for any errors that may inadvertently appear in this document.

AES Pharma Wall System & Walkable Ceiling

Architectural Components

Wall Panels

Introduction

The AES Pharma Cleanroom System wall panel is an aluminum framed composite panel designed for cGMP environments.

Material - Composite PanelThe wall panel is a smooth, white, uPVC- coated, galvanized sheet steel.

Panel FacingThe metal skins of the panel (both sides) consist of 24 gauge (0.7 mm) thick cold rolled galvanized steel (zinc coating of 272 g/m2 to both surfaces).

Surface Finish (both sides)The surface finish of the metal skins is a proprietary blend of 4 mil (0.12µm) thick unplasticized polyvinyl chloride (uPVC).

CoreAES Pharma Wall cleanroom panels are constructed, as standard, with an aluminum honeycomb core. Additional core options are available to suit the requirements of individual projects – such as EPS (expanded polystyrene) and XPS (extruded polystyrene).

Composite Thickness

2” (50mm) thick composite panel

Framing & Extrusions

The AES Pharma Wall panel is framed with an aluminum extruded section incorporating a groove to accept an interconnecting tongue forming a rigid panel to panel construction.

AES Pharma Wall Series wall panels are mounted on an adjustable extruded aluminum floor track that includes a recess for various flooring materials to be coved and finished flush with the face of the cleanroom wall panel.

UL-Rated Raceways The aluminum framing provides 2” x 3” (50mm x 75mm) UL listed vertical raceways for services.

General Information

FDA ComplianceAES Pharma System Wall Panels conform to FDA standards governing raw materials coming in contact with pharmaceuticals.

FM ApprovalsAES Pharma System Wall Panels are approved by Factory Mutuals Approvals for installtion in Factory Mutual Global insured facilities.

System Features

PVC cold-welded seams - No caulk•

PVC floor/ceiling coves - No exposed metal•

UL-rated raceway for electrical service•

Non-combustible•

Non-outgassing•

Impact resistant•

ManufacturingAES Pharma Systems wall panels are manufactured by AES Clean Technology, Inc., under controlled factory conditions in accordance with AES Clean-Build Protocol. The face of each AES wall panel is protected by a polyethylene sheet prior to crating. The poly film protection remains on the wall and ceiling panels until completion of installation in the field, prior to PVC cold-welding.

Quality AssuranceAES implements and maintains a comprehensive program for the

AES PHARMA SYSTEM



full-scope of manufacture from material receiving through crating and shipping finished product. Finished panels are individually inspected, numbered, and receive a quality control check label prior to crating. AES maintains a Quality Control Inspection Report for each shipment.

Installation

The AES Pharma Wall and Walk-On Ceiling System is sold as an installed system. Installation is performed in the field by technicians trained in the AES Pharma System.

Assembly of the system is governed by AES clean-build protocol and AES modular project execution best practices, systematized into the Construction Quality Plan (CQP) to ensure that quality is built into process as work is performed, as opposed to being checked during commissioning activity. The QCP describes the overall strategy, specifies the required steps and corresponding deliverable. Roles and responsibilities are defined, as well as turnover points. The audited documentation of the QCP is part of the turnover package to support qualification.

Special attention is given to Current Good Manufacturing Practices (CGMP) processes and the supporting systems, and all systems are installed using Current Good Engineering Practices (CGEP).

Essential principles for installation include:

Inspection of all materials, components, and equipment upon • receipt

Tracking all items through fabrication and installation•

Auditing to ensure all systems are fabricated and constructed in • accordance with specifications

In-process inspections, closeout inspections, formal turnover walk-• downs

Following the AES “Clean-Build Sequence” to isolate dirty • construction activities outside of the cleanroom environment, and to maintaining optimal clean conditions throughout the project.

Architectural Components: Wall Panels, continued

AES PHARMA SYSTEM




PVC Coving

Introduction

As an exclusive design principle, the AES Pharma System coving is the same PVC material as the wall panels, providing an aseptic detail at all wall-to-wall and wall-to-ceiling junctions, to create a homogenous cleanroom system.

Description

3” (75 mm) radius cove•

White, extruded PVC to match wall surface•

Vacuum-formed corner pieces•

Installation

The AES cove is retained in position with a continuous extruded aluminum section, which is installed throughout all junctions where feasible.

PVC WeldsAll wall-to-wall panel joints, ceiling-to-ceiling panel joints, coves and trims, are sealed with a white liquid uPVC system which provides a weld between the adjacent panel surfaces forming a homogeneous finish throughout the cleanroom.

All other room features, including door frames, trims, fixtures and fittings will be sealed with a white, liquid uPVC filler.Alternative sealants will be used when materials are incompatible with the liquid uPVC system, such as glazing and flooring materials.

Benefits

No exposed metal• Easy-to-clean, totally swept detail• Creates a homogenous cleanroom wall system•

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UL Listed Raceway

Introduction

As an exclusive design principle, the AES Pharma System wall panel incorporates a raceway for electrical and process wires and cables.

Dimensions

2” x 3” (50 mm x 75mm)

Certification

Underwriters Laboratories, (UL) has granted Assembly Approval for electrical raceways incorporated into the AES Pharma architectural system, [Prefabricated Buildings] Composite Panels, File Number MH26569. This assembly is under on-going UL follow-up inspections, with the most recent Inspection Report available for review by qualified AES customers.

Voltage

Receptacle: 120/250Light: 120/277

Construction

Two electrical raceways are formed on 4’ centers using the AES Pharma wall panel.

The raceway is a standard component of the wall panel, forming the side frames of each panel. The aluminum extrusion forms an integral conduit for electrical wires to be fed vertically through the wall panel from above the cleanroom.

Benefits

Reduces installation costs•

Speeds placement of wires & cables•

Eliminates wires, surface mounted conduits, etc.•

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AES can offer, as part of the cleanroom scope of work, various flooring systems including vinyl, epoxy and terrazzo.

Floor to Wall Integration

Standard AES Pharma Wall System wall panels are located at the base on an extruded aluminum adjustable floor track. The track is bolted, using anchor bolts to the floor slab. The adjustable floor track is nominally 4” high and sits centrally beneath the 2” wall panel. This allows a recess for the flooring material to be coved and finished flush with the face of the clean room wall panel.

Vinyl

Generally, vinyl flooring can be 1/16” (2mm) thick sheet vinyl in laid in accordance with the manufacturers recommended adhesive and installation methods. Vinyl seams can be heat welded providing an impervious, hard wearing, homogeneous floor finish.

The gap between wall and floor cove will be sealed.

AES can provide any vinyl flooring type such as static dissipative or other types, as required for individual projects and is not limited to specific suppliers.

Epoxy

AES can offer a comprehensive selection of epoxy resin floors from simple coatings to 3/8” (8mm) thick screeds to advanced anti-static systems all suitable for cleanroom applications. The epoxy is, generally, poured out, and trowelled down into a completely monolithic, lightweight, flexible, long lasting/durable, easy to clean, non-porous, chemical and fire resistant seamless flooring system.

Flooring

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